Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Session attendance rate
研究概览
简要总结
Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours.
Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors.
Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically.
Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As trial therapists will perform assessments, blinding is not possible.
入排标准
- 年龄范围
- 11 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 11-to-24 years at the time of randomisation
- •Received treatment for a brain tumour at a participating Principle Treatment Centre
- •Active brain tumour treatment is complete and their condition stable for at least six-months
- •Have sufficient cognitive ability to engage with ACT sessions as judged by the clinician at baseline assessment
- •competent to provide informed consent (participants aged 16 or over) or assent (participants aged 11-15)
- •Parent/carer competent to provide informed consent (for participants aged 11-15)
排除标准
- •Received a structured behavioural intervention within six-months prior to study recruitment
- •Previous or current alcohol/substance dependence, psychosis, suicidality, or eating disorder
- •Moderate or severe intellectual disability, confirmed through researcher judgement at screening through questions relating to school type and previous diagnoses
- •Immediate risk to self or others
- •The patient or their parent/carer is not able to speak, read or write English
结局指标
主要结局
Session attendance rate
时间窗: assessed at 6-month follow-up
The session attendance rate compared to feasibility benchmarks
Treatment completion rate
时间窗: assessed at 6-month follow-up
The proportion of patients showing interest who then consent to the trial and complete the intervention
The credibility/expectancy questionnaire
时间窗: Assessed at session 2
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The experience of service questionnaire
时间窗: Assessed at 6-month follow-up.
A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.
次要结局
- World Health Organisation wellbeing index 5-items(assessed at 3, 6, 9 and 12-month follow-up)
- Acceptance and Action Questionnaire II(assessed at 3, 6, 9 and 12-month follow-up)
- Patient Health Questionnaire 9-items(assessed at 3, 6, 9 and 12-month follow-up)
- Avoidance and Fusion Questionnaire for Youth 8-items(assessed at 3, 6, 9 and 12-month follow-up)
- Generalised Anxiety Disorder assessment 7-items(assessed at 3, 6, 9 and 12-month follow-up)
- Euroqol 5-dimensions 3-levels(assessed at 3, 6, 9 and 12-month follow-up)
- Strengths and Difficulties Questionnaire 25-item(assessed at 3, 6, 9 and 12-month follow-up)
- Experiential interviews(assessed at 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities(assessed at 3, 6, 9 and 12-month follow-up)
- Client Service Receipt Inventory(assessed at 3, 6, 9 and 12-month follow-up)